Device and method for the determination of dry weight by continuous measurement of resistance and calculation of circumference in a body segment using segmental bioimpedance analysis

a technology of resistance and body segment, applied in the field of dry weight determination by continuous measurement of resistance and calculation of circumference in a body segment using segmental bioimpedance analysis, can solve the problems of complex correct interpretation of dialysis signs and symptoms, dry body weight (dw or dry weight), and the management of the dialysis patien

Inactive Publication Date: 2006-06-08
FRESENIUS MEDICAL CARE HLDG INC
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  • Summary
  • Abstract
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AI Technical Summary

Benefits of technology

[0007] The present invention includes a device for continuously calculating the circumference of a body segment, the device comprising: a digital signal processor; an electrical output means being in electrical communication with the digital signal processor and being attachable to the body segment, the electrical output means being adapted to apply electrical current to the body segment; an electrical input means being in electrical communication with the digital signal processor and being attachable to the body segment, the electrical input means being adapted to receive the current transmitted through the body segment and transmit the same to the digital signal processor; and a microprocessor being in electrical communication with the digital signal processor; wherein the microprocessor is adapted to continuously calculate the circumference of the body segment based on the continuous measurement of the extracellular resistance of the body segment. In one embodiment of the device, the microprocessor continuously calculates the circumference of the body segment according to the following equation: χt=χ02-4⁢π⁢ ⁢ρ0⁢LR0⁢(1-R0Rt)

Problems solved by technology

Accurate assessment of a dialysis patient's hydration status and prediction of dry body weight (DW or dry weight) is a major problem in the clinical management of the dialysis patient.
The correct interpretation of such signs and symptoms is complicated by the fact that the pre-treatment body weight varies for each treatment, the amount of excess fluid is not constant and the amount of fluid that can or should be removed from any particular patient during any particular dialysis treatment may be limited by an individual's cardiovascular tolerance, often manifested by clinical signs and symptoms, such as pretibial edema, dyspnea, cramps and / or a decline in blood pressure.
Alternatively, an overestimation of the amount of fluid to be removed may result in potentially avoidable symptoms, unnecessarily lengthy dialysis treatments and often prolonged stays at the dialysis facility.
Therefore, over- or underestimation of DW will significantly affect both the efficiency of dialysis treatment and patients' quality of life.
However, Kouw's method cannot be used to measure interstitial fluid alone as it does not distinguish between interstitial fluid and plasma, both of which make up the ECV compartment.
While this technique could be used to compare the subjects' body hydration, it is unable to predict individual patient's dry weight because of the significant variation in measured values.
Blood volume measurement is a noninvasive technique that can be used to indicate water concentration in blood, i.e. hematocrit, during hemodialysis, but it cannot be used to directly determine dry weight because changes in blood volume are mainly dependent on the rate of vascular refilling which, in part, is independent of body hydration.
On the other hand, since a change in the hematocrit level may alter conductivity in the blood during dialysis, it is difficult to obtain information about tissue hydration by either traditional bioelectrical impedance analysis or blood volume analysis.
To date, a major problem has been how to measure resistivity of blood and tissue separately, in order to estimate the fluid volume in the intravascular compartment and the interstitial compartment, respectively.

Method used

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  • Device and method for the determination of dry weight by continuous measurement of resistance and calculation of circumference in a body segment using segmental bioimpedance analysis
  • Device and method for the determination of dry weight by continuous measurement of resistance and calculation of circumference in a body segment using segmental bioimpedance analysis
  • Device and method for the determination of dry weight by continuous measurement of resistance and calculation of circumference in a body segment using segmental bioimpedance analysis

Examples

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Effect test

example 1

[0081] Twenty healthy subjects (Table 1) and thirteen hemodialysis patients (Table 2) were studied, the latter during hemodialysis. Shown in Tables 1 and 2 are their mean ages, weights and body mass indices (BMI). Data are presented as mean value±SD

TABLE 1Healthy subjectsAgeWeightBMIn(years)(kg)(kg / m2)Male1040.8 ± 583.1 ± 21.627.1 ± 5.0Female10  35 ± 964.3 ± 9.7 24.2 ± 3.2

[0082]

TABLE 2Hemodialysis patientsAgeDry WeightBMIn(year)(kg)(kg / m2)Male1048.5 ± 12.876.8 ± 16.426.8 ± 4.3Female365 ± 1460.5 ± 16  23.7 ± 3.5

example 2

[0083] Segmental bioimpedance was measured continuously every 10 minutes during hemodialysis using 6 electrodes all on the left side of the body. Two electrodes, one on the hand and one on the foot, were used to inject current. Measurement electrodes were placed on the wrist, shoulder, hip and ankle. Resistivity was measured in the wrist-shoulder segment (Varm), the shoulder-hip segment (Vtrunk), and in the ankle-hip segment (Vleg). Also measured were systolic blood pressure (SBP), relative blood volume or hematocrit (RBV), and the ultrafiltration rate (UFR). In this way, blood volume and segmental extracellular volume (ECV) in the leg, arm and trunk were calculated. The results are shown in FIG. 12. The X-axis is time in minutes, the Y-axis the relative change in value with the value of a particular parameter at the start of hemodialysis being equal to 100%. After continuing ultrafiltration changes in ECV of the leg became small that the slope was nearly horizontal i.e. approached ...

example 3

[0084] In this example, we studied 21 hemodialysis patients, dividing them into two groups by clinical estimation of whether they were at clinical dry weight (CDW; number of patients=10, mean age=56.6 years) or were over hydrated (OH; number of patients=11, mean age=66.5 years) (see Table 3 below). For each hemodialysis patient, we measured the resistivity and the rate of change in resistance (Δ slope, or Δδ) during a dialysis session, for a particular body segment. The ratio of regional extracellular volume (ECV) was measured by segmental bioimpedance and compared to regional geometric volume (RGV) for estimation of regional hydration (wherein RGV=cross sectional area (A)·length (L, 10 cm)). Our results, as shown in Table 3 below, indicate that the overhydrated patients (OH) had significantly lower resistivity than the clinical dry weight patients (CDW); however, the rate of change in resistance (Δ slope) during dialysis was not significantly different between the overhydrated pati...

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Abstract

A method and device for continuously calculating the circumference of a body segment is based on the continuous measurement of the extracellular resistance of the body segment. Also disclosed is a method and device for determining the dry weight of a dialysis patient wherein the time at which the dry weight of the patient has been achieved is identified as the time at which the patient's normalized resistivity as a function of time (ρN(t)) is greater than or equal to a minimum level of normalized resistivity in healthy subjects (ρN,H).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims the benefit of U.S. Provisional Application No. 60 / 617,339 (filed Oct. 7, 2004), and this application is also a continuation-in-part of prior U.S. patent application Ser. No. 10 / 305,513 (filed Nov. 27, 2002), which is a continuation-in-part of prior U.S. patent application Ser. No. 09 / 638,657 (filed Aug. 14, 2000), now U.S. Pat. No. 6,615,077. Each of these aforementioned applications are incorporated herein by reference in their entireties.FIELD OF THE INVENTION [0002] The present invention relates to a device and method that utilize segmental bioimpedance for the determination of dry weight by the continuous measurement of resistance and calculation of circumference in a body segment. BACKGROUND OF THE INVENTION [0003] Accurate assessment of a dialysis patient's hydration status and prediction of dry body weight (DW or dry weight) is a major problem in the clinical management of the dialysis patient. In both he...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61B5/103A61B5/05
CPCA61B5/0537A61B5/6843A61B5/022
Inventor ZHU, FANSANLEVIN, NATHAN W.
Owner FRESENIUS MEDICAL CARE HLDG INC
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